What Is Acute GVHD?

Onscreen text and narrator: What Is Acute GVHD?

Onscreen text and narrator: Jakafi^® (ruxolitinib) is the first and only prescription medicine approved by the FDA to treat adults and children 12 years of age and older with acute graft-versus-host disease (GVHD) who have taken corticosteroids and they did not work well enough.

Important Safety Information is discussed later in this video.

Onscreen text and narrator: This video is intended for informational use only and is not medical advice. Your Healthcare Professional is the best source for treatment-related questions and medical advice.

Sandy: Hi. I'm Sandy Allen-Bard, an oncology clinical nurse educator for Incyte. For more than 20 years prior to joining Incyte, I worked with patients who had cancer as well as patients who had stem cell transplants, including those who experienced acute graft-versus-host disease or acute GVHD.

Sandy: Acute GVHD is a serious complication that affects people who had a stem cell or bone marrow transplant using cells from another person.

Sandy: In Figure A, the patient is receiving a transplant using cells from another person, referred to as donor cells. In Figure B, those healthy immune cells from the donor—now inside the patient—recognize the patient’s body as foreign and begin attacking it.

Sandy: The medical term for the patient is the “host,” while the transplanted cells they’ve received are called the "graft."

Sandy: That's why the condition is called "graft-versus-host disease," or GVHD for short.

Sandy: Acute GVHD mainly affects the skin, liver, and gastrointestinal—or GI—tract. Your GI tract (also known as your digestive tract) includes your stomach, intestines, and colon.

Sandy: Patients may experience symptoms or other health problems in any of these organs because of acute GVHD.

Sandy: Acute GVHD usually happens within the first 3 months after transplant, but it can sometimes start or return 3 or more months after transplant.

Sandy: If acute GVHD does occur, treatment usually begins with medicines to suppress the patient’s immune system.

Sandy: Steroids (also known as corticosteroids) are the standard treatment for patients with newly diagnosed acute GVHD.

Sandy: Although steroid treatment is successful for some patients, others do not respond initially or do not fully respond.

Onscreen text: Not all patients respond initially or do not fully respond to steroid treatment. This is known as steroid-refractory acute GVHD.

Sandy: When patients don’t respond well enough to steroids—either because they didn’t have the desired effect or because they required high doses that could not be reduced—they are said to have steroid-refractory acute GVHD.

Sandy: When steroids don’t work well enough, a different type of therapy may be given.

Sandy: If you or a loved one has acute GVHD and it has not responded to therapy with steroids, ask your Transplant Team about Jakafi^® (ruxolitinib).

Onscreen text: Your treatment journey depends on your individual circumstances and the decisions you make with your Transplant Team. Results may vary.

Sandy: Talk to your Transplant Team to discover if Jakafi may be an option for you.

Sandy: Now let's review the Important Safety Information for Jakafi.

Onscreen text and narrator: Important Safety Information

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi^® (ruxolitinib) may cause low platelet, red blood cell, and white blood cell counts. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will do a blood test to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

Cancer: Some people have had certain types of non-melanoma skin cancers during treatment with Jakafi. Your healthcare provider will regularly check your skin during your treatment with Jakafi. Tell your healthcare provider if you develop any new or changing skin lesions during treatment with Jakafi.

Increases in cholesterol: You may have changes in your blood cholesterol levels during treatment with Jakafi. Your healthcare provider will do blood tests to check your cholesterol levels about every 8 to 12 weeks after you start taking Jakafi, and as needed.

Increased risk of major cardiovascular events such as heart attack, stroke or death in people who have cardiovascular risk factors and who are current or past smokers while using another JAK inhibitor to treat rheumatoid arthritis: Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Jakafi, including: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back, severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw, pain or discomfort in your arms, back, neck, jaw, or stomach, shortness of breath with or without chest discomfort, breaking out in a cold sweat, nausea or vomiting, feeling lightheaded, weakness in one part or on one side of your body, slurred speech

Increased risk of blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in people taking another JAK inhibitor for rheumatoid arthritis and may be life-threatening. Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with Jakafi, including: swelling, pain, or tenderness in one or both legs, sudden, unexplained chest or upper back pain, shortness of breath or difficulty breathing

Possible increased risk of new (secondary) cancers: People who take another JAK inhibitor for rheumatoid arthritis have an increased risk of new (secondary) cancers, including lymphoma and other cancers. People who smoke or who smoked in the past have an added risk of new cancers.

The most common side effects of Jakafi include: for certain types of myelofibrosis (MF) and polycythemia vera (PV) – low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea; for acute GVHD – low platelet counts, low red or white blood cell counts, infections, and swelling; and for chronic GVHD – low red blood cell or platelet counts and infections including viral infections.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Call your doctor for medical advice about side effects.

Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had low white or red blood cell counts, have or had tuberculosis (TB) or have been in close contact with someone who has TB, had shingles (herpes zoster), have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have high cholesterol or triglycerides, had cancer, are a current or past smoker, had a blood clot, heart attack, other heart problems or stroke, or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change your dose or stop taking Jakafi without first talking to your healthcare provider.

Women should not take Jakafi while pregnant or planning to become pregnant. Do not breastfeed during treatment with Jakafi and for 2 weeks after the final dose.

Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also report side effects to Incyte Medical Information at 1-855-463-3463.

Sandy: Visit jakafi.com to learn more about the possible risks and benefits of Jakafi for the treatment of acute GVHD for patients who have already taken corticosteroids and they did not work well enough.

Onscreen text: Please visit Jakafi.com to learn more.

This video is sponsored by Incyte Corporation.
Jakafi and the Jakafi logo are registered trademarks of Incyte.
© 2020, Incyte Corporation. MAT-JAK-03462  12/21